The U.S. Food and Drug Administration's Center for Drug Evaluation and Research

(CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena ...

How effective is the Mckenna shot?

In the trial, the preterm birth rate in the Makena group (36%) was roughly what would be expected in women who had previously delivered a baby prematurely. The drug appeared to be effective only because the women given the placebo had an extraordinarily high rate of preterm birth (55%).

What is the work of hydroxyprogesterone?

Hydroxyprogesterone is a form of progestin, a manmade form of a female hormone called progesterone. Hydroxyprogesterone is used to lower the risk of premature birth in a woman who has already had one premature baby. Hydroxyprogesterone will not stop premature labor that has already begun.